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CLASS II · ModerateFDA

Beckman Coulter, Inc. recalls ROTOR ASSY-SW41

📅 Sep 21, 2026 · 📍 Nationwide
Recalling company
Beckman Coulter, Inc.
Product
ROTOR ASSY-SW41, Reference Number 331362, when the rotors are installed in the following centrifuges: Optima XPN-100 (Model Numbers A99846 and A94469), Optima XPN-90 (Model Numbers A99842 and A94468), Optima XPN-80 (Model Numbers A99839 and A95765), Optima XE-100 (Model Numbers A99836 and A94516), and Optima XE-90 (Model Numbers A99833 and A94471)
Reason
Rotors have been found with a non-conforming microstructure, which may result in some rotors breaking into two or more pieces during use. Rotors that break into multiple pieces during use may result in significant damage to materials (i.e., samples) being processed in the centrifuge and to the centrifuge instrument.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Sep 21, 2026
Reported
Oct 28, 2026
Distribution
US Nationwide distribution.
Status
Ongoing
Quantity
336 units
Lot / codes
Serial Numbers: 24U15250 to 26U15766; Optima UDI-DI: A99846 - 15099590416324, A99842 - 15099590415754, A99839 - 15099590415822, A99836 - 15099590415846, A99833 - 15099590415860
Company location
Indianapolis, IN
Recall type
Voluntary: Firm initiated
Recall number
Z-0202-2027
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0202-2027 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.